Solara Shares New Updates On Ranitidine Hydrochloride API

Solara Active Pharma Sciences Ltd (Solara) (NSE: SOLARA; BSE: 541540) today shared updates on its Ranitidine API as USFDA publishes a statement on April 1, 20201, requesting all finished dosage formulations manufacturers to withdraw prescription and over-the-counter (OTC) Ranitidine drugs in all dosage formats from the US market immediately.

As per USFDA’s statement, the agency has determined that the NDMA impurity in some Ranitidine formulation products increases over time and when stored at higher than room temperatures it may result in consumer exposure to unacceptable levels of NDMA impurity. As a result of this immediate market withdrawal request for all Ranitidine products, Solara has stopped further manufacturing and distribution of Ranitidine API for the US market. The Company shall engage with its formulation partners to understand the next steps and additional data that it needs to generate for supporting their product’s relaunch to the market in an extended period.

Ranitidine API is amongst its top 10 APIs for Solara and contributes ~7% to its total revenues. Solara does not foresee any significant impact on its growth trajectory and continues to maintain a positive outlook for the future.

Shares of Solara Active Pharma Sciences Ltd was last trading in BSE at Rs.456.4 as compared to the previous close of Rs. 443.15. The total number of shares traded during the day was 495 in over 96 trades.

The stock hit an intraday high of Rs. 456.45 and intraday low of 437.4. The net turnover during the day was Rs. 222673.-Equity Bulls